AIM ImmunoTech Inc (NYSE:AIM) announced it had submitted a pre-investigational New Drug application (pre-IND) to the US Food and Drug Administration (FDA) for two separate Phase 2 clinical studies to study Ampligen as both an infusion and an intranasal therapy for early-onset coronavirus (COVID-19).
"With Ampligen’s recently established intranasal safety profile, and the preliminary results from these trials, we may be able to show that Ampligen not only has an early-onset therapeutic effect against a broad spectrum of respiratory viruses, but also may provide a boost to post-infection immunity that will confer cross-protection against viral variants," AIM CEO Thomas K. Equels said in a statement.
"We believe the clearly defined exploratory endpoints for the upcoming trials will substantially validate the significant potential of Ampligen.
READ: AIM ImmunoTech files provisional patent for Ampligen as a potential early-onset intranasal therapy
"Moreover, as the principal architect of AIM’s developing portfolio of COVID-19-related inventions, I personally believe our most recent provisional patent application for Ampligen, as an early-onset intranasal therapy, stands out as an extremely important development in the progression of our patent portfolio."
The two trials will be double-blind and placebo-controlled. One will assess the drug as an intravenous therapy, using 200 mg of Ampligen or placebo, with five doses over 17 days.
The other will look at it as an Intranasal therapy, using 1,250 μg spray (625 μg per nostril), with seven doses over 15 days.
AIM believes it is critical to test both approaches for the drug as there is science to support this, it said.
On Monday, the group said it had submitted a provisional patent application for Ampligen as a potential early-onset intranasal therapy.
This therapeutic use is designed to enhance and expand infection-induced immunity, epitope spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses, such as influenza, Rhinoviruses and SARS-CoV-2, which causes COVID-19, it added.
The immuno-pharma company is also focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases.
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